New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
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FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
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Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more
The FDA published its first draft guidance on the use of AI in the development of drugs and biological products ...
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FDA kicks off new year with draft guidance on skin biopsies in trials
The US Food and Drug Administration has issued guidance urging sponsors and trial sites to consider the necessity of the ...
The FDA Set Guidelines for 'Acceptable' Levels of Lead in Baby Food for the First Time — but Some Experts Say It's Not Enough
On Monday, the U.S. Food and Drug Administration (FDA) announced that, for the first time, it is setting guidelines for an ...
FDA sets new lead level guidelines for baby foods
For the first time in history, the U.S. Food and Drug Administration has established guidance for levels of lead in processed ...
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FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions
The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support ...
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FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis
FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information ...
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The FDA sets new lead limits in baby food—but is it enough to protect babies?
The FDA’s new action levels set the following limits on lead content in processed foods for babies and young children: 1 0 ...
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FDA draft guidance on labeling of plant-based foods ‘unfairly burdensome,’ says PBFA
The FDA does not favor commonly used descriptors such as ‘plant-based burger' on labels and suggests brands instead say ...